CTRI

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CTRI Number

CTRI/2016/12/007529 [Registered on: 02/12/2016] Trial Registered Retrospectively

Last Modified On:

11/12/2018

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Randomozed,Blinded, placebo controlled, clinical study to evaluate the efficacy of Dabur Babool Neem Toothpaste DRDC/PC/8003 in oral hygeine and dental care

Scientific Title of Study

A Double blind, randomized, placebo controlled, clinical study to evaluate the efficacy of a Dabur Babool Neem Toothpaste DRDC/PC/8003 in oral hygeine and dental care

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Rahul Bhowate
Designation	Professor
Affiliation	Department of Oral medine & Radiology, Sharad Pawar Dental College & Hospital, Wardha
Address	Department of Oral medine & Radiology, Sharad Pawar Dental College & Hospital, Wardha Wardha MAHARASHTRA 442001 India
Phone	07152245968
Fax
Email	dr_bhowate@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Arun Gupta
Designation	Head-Medical Affairs & Clinical Resaerch
Affiliation	Dabur India ltd.
Address	Dabur Research & Development Center, Dabur India Ltd., Sahibabd, Ghaziabad (U.P) Ghaziabad UTTAR PRADESH 201010 India
Phone	012033878614
Fax
Email	arun.gupta@dabur.com

Details of Contact Person
Public Query

Name	Sunil Kumar
Designation	Research Scientist
Affiliation	Dabur India ltd.
Address	Dabur Research & Development Center, Dabur India Ltd., Sahibabd, Ghaziabad (U.P) Ghaziabad UTTAR PRADESH 201010 India
Phone	0120338562
Fax
Email	sunil.kumar@dabur.com

Source of Monetary or Material Support

Dabur India Ltd

Primary Sponsor

Name	Dabur India Ltd
Address	Dabur Research & Development Center, dabiu India Ltd., Sahibabd, Ghaziabad (U.P
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rahul Bhowate	Department of Oral Medicine & Radiology, Sharad Pawar Dental College & Hospital	DEPARTMENT OF ORAL MEDICINE & RADIOLOGY SHARAD PAWAR DENTAL COLLEGE SAWANGI (MEGHE) WARDHA (MAHARASHTRA) PIN - 442004 Wardha MAHARASHTRA	07152245968 dr_bhowate@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Instittutional Ethics Committee, Datta Meghe Institute of Medical Sciences University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	(1) ICD-10 Condition: K051\|\|Chronic gingivitis, (2) ICD-10 Condition: K053\|\|Chronic periodontitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dabur Babool Neem Toothpaste (DRDC/PC/8003)	Subject were advised to brush with Babool Neem Toothpaste two times a day for 12 week
Comparator Agent	Placebo	Subjects were advised to brush two times a day for 6 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	Periodontitis & Gingival Group: 1. Subjects of both sexes in the age groups of 18-45 yrs 2. Subjects willing to sign informed consent form 3. Subjects who have at least 20 natural uncrowned teeth excluding third molars. 4. Subjects with periodontitis and gingivitis 5. Subjects with ability to comply with all study requirements. 6. Subjects having gingivitis with gingival index > 1 at more than 60 % of sites examined. 7. Subjects with tooth stains. 8. Subjects having dental plaque with plaque index of 2 or more. Healthy Group: 1. Healthy subjects of both sexes in the age group of 18 to 45 years. 2. Subjects willing to sign informed consent form. 3. Subjects who have at least 20 natural uncrowned teeth excluding third molars. 4. Subjects with ability to comply with all study requirements.

ExclusionCriteria

Details

Periodontitis & Gingival Group:
1. Subjects having pain and multiplicity of periodontal/gingival problems or advanced generalized chronic inflammatory periodontal disease or any gross oral pathology.
2. Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.
3. Subjects having any serious systemic disease.
4. Subjects with any external dental treatment like scaling, polishing, flossing etc.
5. Subjects with Upper respiratory tract infection, Urinary tract infection, Gastrointestinal Tract infection, Skin infection.
6. Subjects with history of intake of antibiotics and anti-inflammatory drugs for the past 3-4 weeks
7. Subjects with history of fluoride treatment for the past two weeks.
8. Pregnant or lactating mothers.
9. Subjects with involvement in any concurrent study the nature of which may affect the parameters being investigated in the study.
10. Subjects not willing to sign informed consent.
11. Subjects not willing to come for follow-up when required
12. Subjects with presence of relatively severe tetracycline stained teeth.

Healthy Group:
As per the exclusion criteria for gingivitis & periodontitis group.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
For GIngivitis & Periodontitis Group: change in scores of gingivitis &/or signs & symptoms, change in microbiologiacl assesment (swab culture), elimination/reduction in malodor if applicable, change in scores of lobene stain &/or signs & symptoms, change in plaque scores &/or signs & symptoms, change in clinivcal attachement loss For Healthy Group: Reduction in microbial counts (swab culture)	12 weeks for gingivits & periodontitis group & 6 weeks for healthy group

Secondary Outcome

Outcome	TimePoints
For GIngivitis & Periodontitis Group: Global patient & Investigator evaluation, ADR/AE profile For Healthy Group: Lobene index, organoleptic index, plaque assesment/plaque index, gingival index, clinical attachment loss, ADR/AE profile	12 weeks for gingivits & periodontitis group & 6 weeks for healthy group

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

N/A

Date of First Enrollment (India)

24/09/2010

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="8"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Result s of the study of this clinical Trial may be used for publishing scientific papers.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This is a single centerd, Double Blind; Placebo Controlled; randomized, clinical study to evaluate the efficacy of a Dabur Babool Neem Toothpaste in oral Hygiene and Dental Care. 50 subjects were enrolled in the study on the basis of two groups one group is diseased group having Gingivitis and Periodontitis and 20 Healthy Volunteers were enrolled in other group. For Gingivitis and Periodontitis group Duration of the study was 12 weeks of use of product and one week follow up where as in Healthy group duration of study was 6 weeks of use of product.Subjects were assessed on various parameters like: Change in pH of saliva,change in pH of gingival crevicular fluid,change in gingival crevicular flow,reduction in microbial counts (swab culture)change in malodor,change in stain score,change in gingival index,change in plaque scores,change in clinical attachment loss scores,global patient evaluation,global physical evaluation,Adverse Reactions/Adverse Events.